Randomized Comparison of Everolimus- and Paclitaxel-Eluting Stents: 2-Year Follow-Up From the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV Trial

• Published in: Journal of the American College of Cardiology 2011-06, Vol.58 (1), p.19-25
• Main Authors: STONE, Gregg W, RIZVI, Ali, KEREIAKES, Dean J, SUDHIR, Krishnankutty, NEWMAN, William, APPLEGATE, Robert J, CANNON, Louis A, MADDUX, James T, CUTLIP, Donald E, SIMONTON, Charles A, SOOD, Poornima
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Biological and medical sciences; Cardiology; Cardiology. Vascular system; Clinical outcomes; Coronary heart disease; Coronary Restenosis; Drug therapy; Drug-Eluting Stents; Everolimus; Follow-Up Studies; Heart; Heart attacks; Humans; Immunosuppressive Agents - administration & dosage; Medical sciences; Middle Aged; Paclitaxel - administration & dosage; Prospective Studies; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Sirolimus - administration & dosage; Sirolimus - analogs & derivatives; Stents; Thrombosis - prevention & control; Treatment Outcome; Tubulin Modulators - therapeutic use
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2011.02.022

We sought to determine whether the differences in outcomes present between everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial at 1 year were sustained with longer-term follow-up. In the SPIRIT IV trial, patients undergoing percutaneous coronary intervention who were randomized to EES compared with PES experienced lower 1-year rates of target lesion failure (cardiac death, target vessel myocardial infarction [MI], or ischemia-driven target lesion revascularization [TLR]), with significant reductions in the individual rates of MI, TLR, and stent thrombosis. We prospectively randomized 3,687 patients with up to 3 noncomplex previously untreated native coronary artery lesions to EES versus PES at 66 U.S. sites. Follow-up through 2 years is complete in 3,578 patents (97.0%). Treatment with EES compared with PES reduced the 2-year rates of TLF (6.9% vs. 9.9%, p = 0.003), all MI (2.5% vs. 3.9%, p = 0.02), Q-wave MI (0.1% vs. 0.8%, p = 0.002), stent thrombosis (0.4% vs. 1.2%, p = 0.008), and ischemia-driven TLR (4.5% vs. 6.9%, p = 0.004), with nonsignificantly different rates of all-cause and cardiac mortality. Between 1 year and 2 years, there were no significant differences in adverse event rates between the 2 stent types. In the large-scale, prospective, multicenter, randomized SPIRIT IV trial, the benefits of EES compared with those of PES present at 1 year were sustained at 2 years.